- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06158945
The Role of Endothelin 1 as a Marker of Renal Impairment in Sickle Cell Disease
December 5, 2023 updated by: Esraa Anwar Qenawy, Sohag University
Sickle cell disease (SCD) refers to a group of hemoglobinopathies that include mutations in the gene encoding the beta subunit of hemoglobin.
Within the umbrella of SCD, many subgroups exist, namely sickle cell anemia (SCA), hemoglobin SC disease (HbSC), and hemoglobin sickle-beta-thalassemia (beta-thalassemia positive or beta-thalassemia negative).
Several other minor variants within the group of SCDs also, albeit not as common as the varieties mentioned above.
It is essential to mention the sickle cell trait (HbAS), which carries a heterozygous mutation and seldom presents clinical signs or symptoms.
Sickle cell anemia is the most common form of SCD
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alzahraa A Ahmed, professor
Study Contact Backup
- Name: Esraa A Quenawey, resident
- Phone Number: 01026841188
- Email: esraaanwar@med.sohag.edu.eg
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag University Hospital
-
Contact:
- Magdy M Amin, Professor
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
The patients fulfilling all the following criteria will be included:
Patients with sickle cell disease in the age range of 1-18years
Description
Inclusion Criteria:
- The patients fulfilling all the following criteria will be included:
- Patients with sickle cell disease in the age range of 1-18years.
Exclusion Criteria:
- Patients diagnosed to have coexistent renal disease before the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
renal affection in sickle cell patients
Time Frame: 1 year
|
assessment of urinary endothelin 1 as a marker of renal impairment in sickle cell patients
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Platt OS. Sickle cell anemia as an inflammatory disease. J Clin Invest. 2000 Aug;106(3):337-8. doi: 10.1172/JCI10726. No abstract available.
- Williams TN, Thein SL. Sickle Cell Anemia and Its Phenotypes. Annu Rev Genomics Hum Genet. 2018 Aug 31;19:113-147. doi: 10.1146/annurev-genom-083117-021320. Epub 2018 Apr 11.
- Lonergan GJ, Cline DB, Abbondanzo SL. Sickle cell anemia. Radiographics. 2001 Jul-Aug;21(4):971-94. doi: 10.1148/radiographics.21.4.g01jl23971.
- Nath KA, Katusic ZS. Vasculature and kidney complications in sickle cell disease. J Am Soc Nephrol. 2012 May;23(5):781-4. doi: 10.1681/ASN.2011101019. Epub 2012 Mar 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2023
Primary Completion (Estimated)
October 23, 2024
Study Completion (Estimated)
October 23, 2024
Study Registration Dates
First Submitted
November 28, 2023
First Submitted That Met QC Criteria
December 5, 2023
First Posted (Actual)
December 6, 2023
Study Record Updates
Last Update Posted (Actual)
December 6, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- soh_Med_23_10_01MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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HemaQuest Pharmaceuticals Inc.TerminatedSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SUnited States, Lebanon, Egypt, Canada, Jamaica
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HemaQuest Pharmaceuticals Inc.CompletedSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SUnited States, Lebanon, Canada, Egypt, Jamaica
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